1. The Field of the Invention
The present invention relates generally to medical instruments used to access the cavity of the uterus. More particularly, it concerns a cervical retractor apparatus to assist placement of other instruments into the cavity of a uterus, or to better visualize the cervix or upper vagina for the purposes of colposcopy and/or biopsy. The apparatus will also provide intraperitoneal retraction and exposure via laparoscopy.
2. The Background Art
It is common practice to place traction on the cervix during various medical procedures to straighten out the uterus. In gynecology, the need often arises to place instruments into the cavity of the uterus (e.g., artificial insemination devices, curettes, biopsy instruments, and radiologic devices to instill dye). Unfortunately, the canal of the uterine cervix is often curved such that placing an instrument into the uterus is difficult. By placing traction on the cervix, the canal may be straightened out so that instruments can then be more easily introduced. The most common instrument used to grasp the cervix is a tenaculum. A tenaculum is a self-retaining ratcheting stainless steel instrument with two or more sharp points that actually pierce the cervix in order to grasp the cervix. A tenaculum is typically used in an operating room setting when the patient is anesthetized. The tenaculum is used to apply a great amount of counter-traction on the cervix so that dilators can be passed into the cervix to widen the opening in order to pass larger instruments into the uterus.
Problems with the tenaculum include the relatively large diameter points on the xe2x80x9ctongxe2x80x9d portion which frequently cause bleeding and may require suturing to stop the bleeding. Also, application by the physician of excessive traction can pull off cervical tissue causing lacerations. Despite such problems, the tenaculum is preferred over clamping devices because the latter tend to slip off, lacerate large portions of the cervix, or crush and devitalize the tissue. While cervical infections are quite rare with the use of a tenaculum, in the awake patient, as the tenaculum pierces and compresses the cervix, considerable cramping and discomfort are often experienced by the patient.
Most gynecologists frequently use a tenaculum in the office, and thus keep a supply of them. A speculum is first inserted into the vaginal opening to hold open the surrounding tissue to allow access to and visualization of the cervix of the patient. If the tenaculum is to be used on an awake patient, the local area of the cervix is most often infiltrated first with a local anesthetic via a small gauge needle. A tenaculum in an outpatient awake setting may be utilized to:
1. Introduce Pipelle(copyright)xcx9cand other brand suction aspirators;
2. Introduce curettes;
3. Facilitate office hysteroscopy;
4. Perform difficult intrauterine inseminations;
5. Sound (measure) the uterine cavity;
6. Facilitate hysterosalpingography;
7. Perform difficult transfer of embryos;
8. Stabilize the cervix for biopsy;
9. Provide exposure for colposcopy; and
10. Facilitate paracervical anesthetic blocks.
In advanced reproductive technology such as in vitro fertilization, a critical step in the process is placement of embryos directly into the uterine cavity. It is believed that the more bleeding and cramping that is caused by this procedure, the less the pregnancy implantation rate. Therefore, the use of the tenaculum during in vitro fertilization procedures has been shunned. Instead, thin catheters of various designs and flexibility have been manufactured to pass the embryos directly into the uterus without the need to manipulate the cervix or uterus. Another approach has been to utilize a small suture through the lip of the cervix using a tiny atraumatic curved needle to pierce the cervix. The use of such a small suture has proved to cause less bleeding and cramping compared to performing the procedure with a tenaculum. Using a suture to pierce the cervix, however, is quite cumbersome and requires a needle driver.
A skin hook (e.g., a Cottle Skin Hook manufactured by MILTEX in Lake Success, N.Y.) is another device that may be employed for insertion through the cervix to perform some of the above-discussed procedures. A skin hook, however, has several drawbacks. First, the handle of a typical skin hook is too short to properly reach into the vagina. In addition, there is no way to keep the skin hook in place, requiring continuous traction. Moreover, the angle of the hook is such that it can often be applied but cannot be readily removed due to the restricted mobility when the skin hook is used in the confines of the vagina.
Some of these same problems confront the gynecologist when using a tenaculum. For example, in order to maintain proper traction on the cervix, either the gynecologist must hold the tenaculum with one hand while performing the desired procedure with the other hand or an medical assistant must be present to hold the tenaculum in place while the gynecologist performs procedures that require both hands. In many situations, it is not convenient to require the help of a medical assistant and it may not be easy to perform the desired procedure with one hand. In either case, it may not be desirable to vary the amount of traction on the cervix depending on the amount of force applied by the hand of either the gynecologist or the medical assistant.
Thus, it would be advantageous to provide an apparatus that can be utilized to perform the previously mentioned procedures as well as other procedures where retraction of the cervix is desired, that produces only one puncture site in the cervix, has self-retention capabilities, that substantially eliminates tissue compression, and minimizes bleeding, infection potential, and other types of trauma to the cervix.
It is an object of the present invention to provide a cervical retractor that causes minimal pain, bleeding and cramping.
It is another object of the present invention to provide a cervical retractor which is simple in design and easy to manufacture.
It is a further object of the present invention to provide a cervical retractor that is disposable in whole or in part.
It is another object of the present invention to provide a cervical retractor capable of placing instruments into a patient""s uterus cavity.
It is a further object of the present invention to provide a cervical retractor which is portable and capable of being carried and operated by hand.
It is yet another object of the present invention to provide a cervical retractor that illuminates the cervix and/or surrounding tissue.
It is still another object of the present invention to provide a cervical retractor that may also provide a lavage or suction and injection of medication.
It is yet another object of the present invention to provide a cervical retractor that is attachable to a standard speculum to facilitate a variety of procedures.
It is still another object of the present invention to provide a cervical retractor that allows visualization of the procedure site. Another object of the present invention is to provide a spiral retractor for use through a laparoscope allowing retraction with self-retention for the purpose of exposure and visualization of such organs as the uterus and ovaries.
The above objects and others not specifically recited are realized in specific illustrative embodiments of a spiral cervical retractor.
In accordance with the present invention, an apparatus for insertion into and removal from the cervix of a patient comprises a wire tipped device, the wire preferably having a spiral or curved configuration. The cervical retractor preferably includes a substantially elongated handle sized to fit within the vagina of a patient, having a spiral wire or hook associated with a distal end of the handle and means for rotating the spiral wire associated with the proximal end of the handle.
The elongated handle is preferably comprised of a substantially rigid traction type handle that may be held in a substantially stationary position relative to the vagina of a patient. Moreover, the means for rotating the spiral wire may comprise a knob or gripping portion rotatably associated with the proximal end of the handle and that is coupled or linked to the spiral wire such that rotation of the knob results in corresponding rotation of the spiral wire.
The spiral wire is preferably of a size and material that will provide relatively high tensile strength while having at least some lateral flexibility.
In a preferred embodiment, the cervical retractor is made of made of relatively inexpensive materials, such as plastics, and is intended to be disposable or easily sterilized after each use.
In yet another preferred embodiment, the spiral tip of the cervical retractor is removable from the handle of the cervical retractor and is intended to be disposable.
In a preferred embodiment, the cervical retractor in accordance with the principles of the present invention includes a cannula that extends the length of the handle and is configured for receiving therein a fiber optic strand for illuminating the site surrounding the cervix of the patient.
In still another preferred embodiment, the cervical retractor includes an elongate cannula configured for connecting to an external device to provide a lavage or suction at the distal end of the cervical retractor as desired.
In yet another preferred embodiment, the cervical retractor in accordance with the principles of the present invention include a device proximate the distal end of the cervical retractor for visualization of the site surrounding the cervix.
In yet another preferred embodiment, the cervical retractor in accordance with the principles of the present invention include a plurality of cannulas through which a plurality of procedures may be performed and a plurality of devices may be inserted.
In still another preferred embodiment, the cervical retractor in accordance with the principles of the present invention comprises an elongate tube housing a retractable rod therein. The retractable rod is provided with a sharpened spiral wire at one end and a hand or gripping portion for manipulation by the gynecologist or other health care professional at the other.
In another preferred embodiment, the retractable rod is biased relative to the tube so that the spiral wire is pulled back into the tube.
In yet another preferred embodiment, the cervical retractor includes an attachment mechanism for grasping a portion of a speculum in order to hold the cervical retractor in place.
In yet another preferred embodiment, the tube of the cervical retractor is configured to receive therein various other devices, for example, a fiber optic strand for providing illumination, a camera lense for visualization, or other instrument housed at least partially within the tube for performing a function at the distal end of the retractor.
Additional objects and advantages of the invention will be set forth in the description which follows, and in part will be apparent from the description, or may be learned by the practice of the invention without undue experimentation. The objects and advantages of the invention may be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims.